Two way crossover bioequivalence study of Pyridostigmine Bromide Tablets 60 mg

Not Applicable

Completed

• Registration Number: CTRI/2014/08/004820
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Healthy human adult literate subjects between 18-45 years of age (inclusive), having a body mass index (BMI) between 18.5 and 25 kg/m2 (inclusive ).

2. Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to study start.

3. Subjects whose screening laboratory values, vital signs, ECG and chest X- ray are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.

4. Nonsmokers or ex-smokers (nonsmokers for at least 3 months)

5. Subjects do not consume any other form of tobacco products.

6. Informed consent given in written form according to section 11.3 of the protocol.

7. Female Subjects

• of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.

• postmenopausal for at least 1 year.

• surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria

Known history of

1. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.

2. Asthma, urticaria or other allergic type reactions after taking any medication.

3. Hypersensitivity to Pyridostigmine and any other similar class of drugs.

4. Mechanical gastro-intestinal or urinary obstruction

History or presence of

1. Significant alcohol dependence, alcohol abuse or drug abuse within past one year.

2. Difficulty in swallowing tablet/capsule.

3. Clinical illness within 4 weeks before the start of the study

1. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the preceding 90 days prior to the start of the study.

2. Subject has donated blood in the preceding 90 days prior to the start of the study.

Subject who have Positive Urine drug screening, Alcohol breath analysis, HIV, VDRL/RPR, Hepatitis B & C tests.

Subjects who have:

1. Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg

2. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.

3. Pulse rate below 60 beats/minute or above 100 beats/minute.

Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax, AUC 0-t, AUC 0-infTimepoint: 0 hr (Pre dose), 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.333, 2.667, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
Tmax, AUCratio, Kel, t½, NKel, TLIN and LQCTTimepoint: 0 hr (Pre dose), 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.333, 2.667, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 hours post dose